BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1040066 · Received May 7, 2008

    Report

    Report Number
    3004209178-2008-02410
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PREGNANT INTERSTIM II PT HAD SEVERE FOOT CRAMPING, AND IT WAS MAKING IT DIFFICULT FOR HER TO WALK. THE HOSPITALIZED PT HAD A HARD TIME ROLLING TO HER SIDE, DUE TO LEG CRAMPING, WHEN THE MDT REP WENT TO TURN THE DEVICE OFF. THE FOOT CRAMPING BEGAN TO SUBSIDE ONCE THE DEVICE WAS TURNED OFF. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXPLANTED| LEAD MODEL 3093 LOT # V011358 IMPLANTED